Catheter Precision gets FDA clearance for VIVO system launch

Catheter Precision has secured Food and Drug Administration (FDA) approval for the launch of its new View into Ventricular Onset (VIVO) system in the US market.

VIVO is a non-invasive imaging system that offers 3D cardiac mapping to help with localising the sites of origin of idiopathic ventricular arrhythmias in patients with structurally normal hearts prior to electrophysiology studies.

The pre-procedure planning tool computer-generates colour-coded 3D mapping images of the heart using magnetic resonance imaging (MRI) or a computed tomography (CT) scan along with a standard 12-lead ΕCG to indicate the area of earliest activation.

Catheter Precision CEO Steve Adler said: “The FDA clearance of the VIVO system puts an important new tool in the hands of electrophysiologists that allows for highly accurate, non-invasive identification of ventricular arrhythmia origins, displayed on a colourised 3D map.

“VIVO uses a proprietary algorithm based on proven electrophysiology principles to generate an accurate 3D model of the heart with a superimposed electrical activation map. These 3D maps help physicians pinpoint the sites of origin for certain types of rhythm disorders.”

The VIVO system comprises a hand-held 3D camera and an off-the-shelf laptop computer.

With the help of lead positions, the chest photograph, and DICOM data, VIVO will be able to determine the precise spatial relationships involved.

It can then provide new cardiac mapping that a physician can use prior to conducting an electrophysiology study and subsequent ablation.

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The French company Ionisos is one of the first companies in the world to have put ionising rays to good use for the sterilisation of medical devices. Originally known as Conservatome (from 1958 to 1993), Ionisos came into being in 1993 following a merger between Conservatome and Amphytrion. Ionisos now offers cold sterilisation for a range of applications.